APX005M in Patients With Recurrent Ovarian Cancer (NCT05201001) | Clinical Trial Compass
WithdrawnPhase 2
APX005M in Patients With Recurrent Ovarian Cancer
Stopped: IMP provider company (Apexigen) is sold, thus both IMP and grant is terminated
Denmark0Started 2023-09-07
Plain-language summary
The overall objective is to demonstrate preliminary efficacy of APX005M-carboplatin-PLD and APX005M-radiotherapy-carboplatin-PLD combinations as treatment for relapsed BRCAwt ovarian cancer patients, where platinum combination therapy is an option.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Have signed an Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to any study-specific evaluation.
✓. Radiological or histological confirmation of relapse disease ≥ 6 month after last chemotherapy
✓. Known BRCAwt
✓. Have completed at least one line of platinum-containing chemotherapy (maximum three previous lines of therapy are permitted). Earlier PARPi treatment permitted
✓. Must have measurable or evaluable disease according to RESIST 1.1.
✓. Baseline biopsy: Tissue biopsy for submission to central laboratory prior to study treatment should be from a newly obtained metastatic biopsy, if there is a lesion suitable for biopsy. If a metastatic biopsy is not feasible, or patient is unwilling to provide new biopsy, archival tissue samples should be submitted. Archival tissue sample from metastatic site is preferred; however, archival tissue sample of primary tumor is acceptable.
✓. Must consent to undergo mandatory tumor biopsy of at least one metastatic site at baseline and at day 84 ( 7). Biopsy at day 84 ( 7) is only applicable if surgery is not performed. -
Exclusion criteria
✕. Previous immunotherapy (for example anti-PD-1/L1).
✕. Other malignancy unless curatively treated with no evidence of disease for ≥ 3years, except adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS) and stage 1 grade 1 endometrial carcinoma.
What they're measuring
1
Overall Response Rate according to RECIST at 12 weeks of treatment
Timeframe: 18 months
Trial details
NCT IDNCT05201001
SponsorNordic Society of Gynaecological Oncology - Clinical Trials Unit
✕. Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation \>500 ms, electrolyte disturbances, etc.), or subjects with congenital long QT syndrome.
✕. Subjects with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML. Page 48 af 128 ENGOT-OV64/NSGO-CTU-SOLERO EudraCT: 2020-005990-29 Final Version 1.0, 06. July 2021
✕. Subjects with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. Subjects with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
✕. Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Subjects who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) or physiologic replacement doses (i.e. prednisone 5 - 7.5 mg/day) for adrenal insufficiency may be enrolled in the study. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
✕. Prior radiation therapy.
✕. Planned concomitant therapy with any other anticancer therapy